liberado em bula

English translation: approved indication(s)

19:12 Dec 14, 2016
Portuguese to English translations [PRO]
Medical - Medical: Pharmaceuticals
Portuguese term or phrase: liberado em bula
With reference to the approval of drugs by Anvisa, can anyone confirm whether "liberado em bula" could be translated as "approved for on-label use"? Or is it "off-label use"?
Marc Vitale
United Kingdom
Local time: 05:47
English translation:approved indication(s)
Explanation:
That's precisely it. I find "on-label" a bit awkward, though.

--------------------------------------------------
Note added at 2 mins (2016-12-14 19:15:33 GMT)
--------------------------------------------------

To clarify: "off-label" use would be the opposite of "liberado em bula".

--------------------------------------------------
Note added at 11 mins (2016-12-14 19:24:25 GMT)
--------------------------------------------------

Hi Marc, I think it fits. You might want to use "...approved the indication" in the first instance and "finally an on-label use" or something along those lines in the second, for example.
Selected response from:

Filippe Vasconcellos de Freitas Guimarães
Brazil
Local time: 01:47
Grading comment
Thank you very much for your help with this.
4 KudoZ points were awarded for this answer



Summary of answers provided
5 +1on-label use
Isadora Vital
4 +2approved indication(s)
Filippe Vasconcellos de Freitas Guimarães
3approved as provided in the insert
Mario Freitas


Discussion entries: 9





  

Answers


0 min   confidence: Answerer confidence 3/5Answerer confidence 3/5
approved as provided in the insert


Explanation:
Sugestão

Mario Freitas
Brazil
Local time: 01:47
Native speaker of: Native in PortuguesePortuguese, Native in EnglishEnglish
PRO pts in category: 4
Login to enter a peer comment (or grade)

2 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +2
approved indication(s)


Explanation:
That's precisely it. I find "on-label" a bit awkward, though.

--------------------------------------------------
Note added at 2 mins (2016-12-14 19:15:33 GMT)
--------------------------------------------------

To clarify: "off-label" use would be the opposite of "liberado em bula".

--------------------------------------------------
Note added at 11 mins (2016-12-14 19:24:25 GMT)
--------------------------------------------------

Hi Marc, I think it fits. You might want to use "...approved the indication" in the first instance and "finally an on-label use" or something along those lines in the second, for example.

Filippe Vasconcellos de Freitas Guimarães
Brazil
Local time: 01:47
Specializes in field
Native speaker of: Native in EnglishEnglish, Native in PortuguesePortuguese
PRO pts in category: 72
Grading comment
Thank you very much for your help with this.
Notes to answerer
Asker: Thanks very much Filippe, so the two phrases I have, in rather awkward Portuguese, are: "o que foi conversado é que ta liberado pela anvisa em bula" and "finalmente uma liberação da anvisa para constar em bula, uma medicação que antigamente era só pra diabete que agora a gente pode usar pra perda de peso". In both these cases, could the translation be "Anvisa has approved the indication"?


Peer comments on this answer (and responses from the answerer)
agree  Matheus Chaud: Também entendi dessa forma: liberado em bula = aprovado pela Anvisa para constar na bula.
7 hrs
  -> Obrigado, Matheus. É exatamente como entendo.

agree  Muriel Vasconcellos
1 day 2 hrs
Login to enter a peer comment (or grade)

8 mins   confidence: Answerer confidence 5/5 peer agreement (net): +1
on-label use


Explanation:
" Using the product in compliance with the FDA required information is referred to as on-label use. "

Acho que poderia também ser usado "approved for on-label use" como você sugeriu...

--------------------------------------------------
Note added at 13 mins (2016-12-14 19:25:48 GMT)
--------------------------------------------------

You could use approved for on-label use, as you suggested.


    Reference: http://www.acehp.org/d/do/1148
Isadora Vital
Brazil
Local time: 01:47
Specializes in field
Native speaker of: Native in PortuguesePortuguese
PRO pts in category: 4

Peer comments on this answer (and responses from the answerer)
agree  Rafael Sousa Brazlate: On-label use basta, acho que não precisa do aprovado.
16 hrs
Login to enter a peer comment (or grade)



Login or register (free and only takes a few minutes) to participate in this question.

You will also have access to many other tools and opportunities designed for those who have language-related jobs (or are passionate about them). Participation is free and the site has a strict confidentiality policy.

KudoZ™ translation help

The KudoZ network provides a framework for translators and others to assist each other with translations or explanations of terms and short phrases.


See also:

Your current localization setting

English

Select a language

Term search
  • All of ProZ.com
  • Term search
  • Jobs
  • Forums
  • Multiple search